BL1332 for Eye Health

Overseen By Celia Busby

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Gabapentinoids, Opioids, NSAIDs, others

Disqualifiers: Pregnancy, Tobacco, Alcohol, others

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6 months

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Single-Center, Phase 1 study to assess the ocular and systemic safety and tolerability of ascending concentrations of topical BL1332 ophthalmic solution eye drops compared with BL1332 vehicle in healthy volunteers, identifying the highest tolerated doses (HTDs)

Eligibility Criteria

This trial is for healthy volunteers who are willing to test a new eye drop solution called BL1332. Participants should not have any ongoing eye conditions or be using other ocular medications that could interfere with the study.

Inclusion Criteria

Written informed consent prior to conduct of any study-related assessment

Vital signs within specified ranges at Screening and Baseline Visit

Body mass index (BMI) between 18.0 and 30.0 kg/m2

Exclusion Criteria

I regularly use pain relievers like acetaminophen or NSAIDs.

I am using eye drops for an ongoing eye condition.

Use of tobacco products within 3 months prior to Screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending concentrations of topical BL1332 ophthalmic solution eye drops to assess safety and tolerability

Approximately 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BL1332 ophthalmic solution
• BL1332 ophthalmic vehicle

Trial Overview The study is testing different strengths of BL1332 eye drops against a placebo (vehicle) to find out which doses are safe and how they affect the body. It's an early-stage, single-center trial focusing on safety and dosage levels.

Participant Groups

Group I: BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) Experimental Treatment 1 Intervention

BL1332 ophthalmic solution (0.06%, 0.15%, and 0.30% concentrations) administered as topical ocular drops

Group II: BL1332 vehicle Placebo Group 1 Intervention

BL1332 vehicle administered as topical ocular drops

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University